Cold chain: difference between revisions
Diff·revision 32 → 33·14:48, 23 Nov 2024
Difference between revision 32 and revision 33 of Cold chain. 5 lines changed; the page grew by 1,076 bytes.
| Revision 32 — 11:43, 15 Nov 2024 StubSorterBot (talk) bot: repair redlinked category 14,208 bytes +790 | Revision 33 — 14:48, 23 Nov 2024 CiteBot (talk) bot: repair redlinked category 15,284 bytes +1,076 | ||
|---|---|---|---|
| 97 | The components are an insulating shell, a coolant, and a payload space arranged so that the coolant neither contacts the product directly nor is separated from it by so much air that it cannot influence it. | 97 | The components are an insulating shell, a coolant, and a payload space arranged so that the coolant neither contacts the product directly nor is separated from it by so much air that it cannot influence it. |
| 98 | 98 | ||
| + | 99 | ; Insulation : Expanded polystyrene, polyurethane and vacuum-insulated panels in ascending order of thermal performance, cost and weight. Vacuum panels achieve roughly an order of magnitude lower conductivity than expanded polystyrene of the same thickness. | |
| + | 100 | ; Coolant : Water ice, gel packs, phase-change materials formulated to melt at a chosen temperature, and dry ice for frozen shipments. Coolant mass and its conditioning before packing are as consequential as its identity. | |
| + | 101 | ; Payload arrangement : A qualified configuration specifies coolant placement, payload volume and the minimum and maximum payload for which the qualification holds. A shipper qualified for a full payload frequently fails when shipped part-full, because the reduced thermal mass follows the coolant more closely.{{r|pda_tr39}} | |
| + | 102 | ||
| 99 | == References == | 103 | == References == |
| 100 | {{reflist}} | 104 | {{reflist}} |
| ⋮ | ⋮ | ||
| 109 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> | 113 | <ref name="lloyd2017">Lloyd J, Cheyne J. "The origins of the vaccine cold chain and a glimpse of the future." ''Vaccine'' 35(17):2115–2120 (2017).</ref> |
| 110 | <ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01). Official Journal of the European Union.</ref> | 114 | <ref name="eugdp2013">European Commission. ''Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use'' (2013/C 343/01). Official Journal of the European Union.</ref> |
| + | 115 | <ref name="pda_tr39">Parenteral Drug Association. ''Technical Report No. 39: Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment''. Revised edition.</ref> | |
| 111 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | 116 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> |
| 112 | 117 |